近红外技术(NIRS)在药物生产过程质量控制中的应用

Application Progress of Near Infrared Spectroscopy(NIRS) in Quality Control of Pharmaceutical Production Process

近红外光谱法(NIRS)具有信息丰富、简便快速、无损检测等特征,已成功应用于制药领域多个生产过程质量控制,是目前应用较为广泛的一种过程分析技术。NIRS技术结合化学计量学和统计学方法,可快速实现药品多个生产过程关键指标的分析,甚至可直接应用于生产线上实现在线、实时、远程分析。通过对过程质量的准确监测,实现药品质量的提升,生产工艺的优化。本文对NIRS技术在化学药、中药以及生物制药等生产过程中的应用进行了综述,以期为提高药物生产过程和质量的可控性提供参考。

The near-infrared spectroscopy(NIRS),as a process analytical technology,with the advantages of its abundant information,rapid,non-destructive,has been successfully applied to the quality control of manufacturing process in the pharmaceutical field.Coupled with methods of chemometric or statistics,NIRS technology can quickly realize the analysis of key indicators in the manufacturing process of medicines and perform on-line,real-time,and remote analysis in production lines.Through accurate monitoring of process quality,the improvement of product quality and the optimization of production process are realized.In this article,the research progresses of NIRS in the production process of chemical medicine,traditional Chinese medicine,and biopharmaceuticals is reviewed to provide references for improving the controllability of the production process and drug quality.